Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
CT05
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2012
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2012
CompletedFirst Posted
Study publicly available on registry
November 8, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFebruary 10, 2015
February 1, 2015
3.2 years
October 31, 2012
February 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the effects on change from baseline on brain atrophy
pre-dose, Months 6, 12, 18, 24 and Washout
Secondary Outcomes (2)
To determine the presence of other biomarkers of neuronal degeneration
Day 1
To determine the presence of other biomarkers of neuronal degeneration
Month 24
Other Outcomes (2)
Change from baseline in cognitive performance
pre-dose, Month 6, Month 12, Month18, Month 24
Change from baseline in global clinical status
pre-dose, Month 6, Month 12, Month 18, Month 24
Study Arms (3)
CHF 5074 1x
EXPERIMENTALoral tablet, multidose
CHF 5074 2x
EXPERIMENTALoral tablet, multidose
Placebo
PLACEBO COMPARATORplacebo, oral tablet, multidose
Interventions
Eligibility Criteria
You may qualify if:
- One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.
- Diagnosis of amnestic Mild Cognitive Impairment.
- Mini-Mental State Examination score higher than 24 at screening.
You may not qualify if:
- Diagnosis of Alzheimer's disease.
- Any medical condition that could explain the subject's cognitive deficits.
- MRI scans having evidence of pre-specified brain abnormalities.
- History of stroke.
- Vitamin B12 or folate deficiency.
- Skin cancers and any cancer that is being actively treated.
- Diagnosis of schizophrenia or recurrent mood disorder.
- Abnormal kidney function.
- Concomitant use of any study prohibitive medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CERESPIRlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel S Ross, MD
Memory Enhancement Center of America
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2012
First Posted
November 8, 2012
Study Start
December 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
February 10, 2015
Record last verified: 2015-02